Boots Max Strength Sinus Pressure & Pain Relief Day & Night Capsules Hard

Document: leaflet MAH BRAND_PL 12063-0074 change

Pack Copy Specification	Max Strength Sinus Relief Day & Night Capsules - Leaflet
Marketing Authorisation number	PL 12063/0074

Paracetamol, Phenylephrine, Caffeine

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you take this medicine because it contains important information you need to know.

This medicine is available without prescription, however, you still need to use this product carefully to get the best results from it. Keep this leaflet as you may need to read it again. Ask your pharmacist if you need more information or advice.

1) What is this medicine and what is it used for?

This medicine contains:

• paracetamol which is a pain reliever (analgesic) and helps reduce your temperature when you have a fever

• phenylephrine which is a decongestant to reduce swelling in the passages of the nose to help you breathe more easily.

The Day capsules also contain:

• caffeine which helps to increase the pain relief from paracetamol and makes you more alert.

The Day capsules are used for the relief of the symptoms of sinus pain and congestion, including relief of aches and pains, headache, fatigue (tiredness) and drowsiness, nasal congestion (blocked nose) and feverishness (high temperature).

The Night capsules are used for the relief of the symptoms of colds and flu, including aches and pains, sore throat, headache, nasal congestion (blocked nose) and feverishness (high temperature).

2. Is this medicine suitable for you?

Do not take this medicine if you:

• are allergic to paracetamol, caffeine, phenylephrine or any of the other ingredients

• have a serious heart condition or cardiovascular disorder(s)

• have high blood pressure (hypertension)

• have a history of stomach ulcers

• have an overactive thyroid

• are taking antidepressant drugs called monoamine oxidase inhibitors (MAOI’s), or have taken them within the last 14 days - these are medicines such as phenelzine and isocarboxazid.

Pack Copy Specification	Max Strength Sinus Relief Day & Night Capsules - Leaflet
Marketing Authorisation number	PL 12063/0074

Please see your doctor or pharmacist before taking this medicine if you:

• are pregnant or breastfeeding

• suffer from kidney or liver problems, including alcoholic liver disease

• have diabetes

• have circulatory disorders such as a condition called Raynaud’s Phenomenon, which results from poor circulation in the fingers and toes.

If you are taking any of the following medicines please see your doctor:

• medicines to treat high cholesterol levels which reduce the amount of fat in the blood such as colestyramine

• medicines to control feeling sick or being sick such as metoclopramide or domperidone

• medicines called anti-coagulants, which are used to thin the blood such as warfarin or other coumarins - you may take occasional doses of paracetamol but should consult your doctor if you need to take it on a regular basis

• barbiturates (for epilepsy or to help you sleep), such as phenobarbitones

• tricyclic antidepressants such as imipramine, amitriptyline

• medicines to lower blood pressure, treat heart or circulatory problems such as beta blockers (e.g atenolol) or vasodilators (e.g hydralazine)

• other decongestant drugs such as ephedrine or xylometazoline.

Contains paracetamol.

Do not take anything else containing paracetamol while taking this medicine. Other important information:

Do not drink alcohol (beer, wine, spirits etc) while taking this product.

3) How to take this medicine

Swallow the capsules whole with water. Do not chew.

Adults, the elderly and children aged 12 years and over:

2 Day capsules every 4 - 6 hours during the daytime, as required, followed by 2 Night capsules at bedtime. Leave at least 4 hours between doses. Do not take more than 8 capsules in any 24 hour period.

Do not give to children under 12 years.

Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.

Note: Does not contain a sleep aid.

Pack Copy Specification	Max Strength Sinus Relief Day & Night Capsules - Leaflet
Marketing Authorisation number	PL 12063/0074

Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

4) Possible side effects

Most people do not have any side effects while taking this medicine. However, if you experience any of the following side effects, or anything else unusual happens, stop taking the medicine immediately, and see your doctor or pharmacist.

Rare side effects are:

• allergic reactions such as skin rash

• tingling and coolness of the skin

• a faster or slower heart beat

• a rise in blood pressure with headache, vomiting (being sick) and irregular heart beat (palpitations)

• nausea (feeling sick) (Day Capsule only)

• difficulty sleeping (insomnia) (Day Capsule only).

More rarely, the following side effects can happen:

• you may become more prone to bleeding, bruising, fever and infections, such as sore throat and ulcers, due to changes in your blood.

Very rare cases of serious skin reactions have been reported.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5) How to store your medicine

Keep all medicines out of the sight and reach of children.

Do not use this medicine after the expiry date printed on the pack.

Do not store above 25°C.

6) What is in this medicine?

Day Capsules: These are red / blue capsules.

Each Day capsule contains the active ingredients: paracetamol 500 mg, caffeine 25 mg and phenylephrine hydrochloride 6.1 mg.

The other ingredients in the Day capsules are: maize starch, croscarmellose sodium, sodium laurilsulfate, magnesium stearate and talc. The capsule shell is made of gelatin

Pack Copy Specification	Max Strength Sinus Relief Day & Night Capsules - Leaflet
Marketing Authorisation number	PL 12063/0074

and contains the colours: quinoline yellow (E104), titanium dioxide (E171), patent blue V (E131), erythrosine (E127) and indigo carmine (E132).

Night Capsules: These are dark blue / light blue capsules.

Each Night capsule contains the active ingredients: paracetamol 500 mg and phenylephrine hydrochloride 6.1 mg.

The other ingredients in the Night capsules are: maize starch, croscarmellose sodium, sodium laurilsulfate, magnesium stearate and talc. The capsule shell is made of gelatin and contains the colours titanium dioxide (E171), erythrosine (E127) and indigo carmine (E132).

This product is available in a pack containing 12 Day Capsules and 4 Night capsules.

7) Who makes this medicine?

The Marketing Authorisation holder and manufacturer is Wrafton Laboratories Limited, Braunton, Devon EX33 2DL, UK.

Text revised: August 2015

PL 12063/0074